Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Goethe University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Goethe University
ClinicalTrials.gov Identifier:
NCT01314235
First received: March 8, 2011
Last updated: March 11, 2011
Last verified: March 2011

March 8, 2011
March 11, 2011
October 2010
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Numbers of participants with an activated area under the curve in ASPI test [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in ASPI test, i.e. an activated area under the curve in Multiplate analysis.
Same as current
Complete list of historical versions of study NCT01314235 on ClinicalTrials.gov Archive Site
Numbers of participants with an activated area under the curve in TRAP test and ADP test [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in TRAP test and ADP test, i.e. an activated area under the curve in Multiplate analysis.
Same as current
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Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel
The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study

Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but also in many other tissues. It is part of balanced anesthesia in general anesthesiology as well as a sedastive agent in intensive care units, but also serves as a third-line agent in many psychiatric diseases including ADHD, schizophrenia and PTSD.

The investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The investigators will use a flowcytometric assay to determine activation of thrombozytes when they come into contact with clonidine in vitro as well as Multiplate analyses to determine activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or arachidonic acid-induced aggregation of thrombozytes.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

patients going under vascular surgery with anticagulation with both ASS and clopidogrel

Anticoagulation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  • Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel
  • Age above 18 years

Exclusion Criteria:

  • Additional anticoagulatoric treatment woth another inhibitor of platelet aggregation
  • Surgery within the last two weeks
  • Patients with long-term mediaction with omeprazole
  • Patients under hemodialysis
  • Patients with renal insufficiency (creatinine above 1.5mg/dl, urea above 80mg/dl)
  • Patients with hepatic dysfunction (GOT above 30U/I, GPT above 30 U/I, GLDH above 10 U/I)
  • Age under 18 yeary
  • Non-responder to ASS and / or clopidogrel
Both
18 Years and older
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Germany
 
NCT01314235
Clonidinstudy
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Philipp Schmidt, Goethe University
Goethe University
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Goethe University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP